compliance Archives - MedCity News https://medcitynews.com/tag/compliance/ Healthcare technology news, life science current events Fri, 15 Sep 2023 22:33:17 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.1 https://medcitynews.com/uploads/2021/03/cropped-mblue-32x32.png compliance Archives - MedCity News https://medcitynews.com/tag/compliance/ 32 32 40682243 CMS Is Getting More Serious About Penalizing Hospitals For Price Transparency Noncompliance https://medcitynews.com/2023/09/cms-hospital-price-transparency/ https://medcitynews.com/2023/09/cms-hospital-price-transparency/#respond Sun, 17 Sep 2023 14:13:14 +0000 https://medcitynews.com/?p=648768

CMS has fined two hospitals in September for alleged violations of its price transparency rule. This marks the third month in a row that the agency has issued fines against hospitals for price transparency noncompliance, following a yearslong period of light enforcement.

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Most Hospitals Are Still Violating HIPAA By Using Web Tracking Tools, Despite Federal Warnings https://medcitynews.com/2023/09/social-media-healthcare-hipaa/ https://medcitynews.com/2023/09/social-media-healthcare-hipaa/#respond Fri, 15 Sep 2023 18:13:35 +0000 https://medcitynews.com/?p=648708

The federal government has warned hospitals that using third-party analytics tools on their websites could violate HIPAA, and more than 20 hospitals are facing class-action lawsuits over the use of these tools. But a recent analysis found that hospitals are doing a poor job of fixing their websites and preventing patient data collection.

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Hospitals’ Price Transparency Compliance Is Improving Despite Remaining Low at 36% https://medcitynews.com/2023/07/healthcare-price-transparency-hospital-cms/ https://medcitynews.com/2023/07/healthcare-price-transparency-hospital-cms/#respond Tue, 25 Jul 2023 16:43:21 +0000 https://medcitynews.com/?p=642552 price transparency

About 36% of U.S. hospitals are in compliance with CMS’ price transparency rule, up from 24.5% in February, according to a new report. This progress will remain slow unless CMS can do a better job of effectively enforcing its rule, the report declared.

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In Rare Move, CMS Fines 2 Hospitals for Price Transparency Violations https://medcitynews.com/2023/04/in-rare-move-cms-fines-2-hospitals-for-price-transparency-violations/ https://medcitynews.com/2023/04/in-rare-move-cms-fines-2-hospitals-for-price-transparency-violations/#respond Thu, 27 Apr 2023 23:16:27 +0000 https://medcitynews.com/?p=632820 price transparency

CMS recently fined two hospitals for alleged violations of its price transparency rule. These fines are only the third and fourth penalties issued by the agency since the rule took effect on January 1, 2021. These fines may become more common — CMS also announced that it is updating its enforcement process for the rule.

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Amid Economic Uncertainty, Health Systems Prioritize ROI https://medcitynews.com/2023/03/amid-economic-uncertainty-health-systems-prioritize-roi/ https://medcitynews.com/2023/03/amid-economic-uncertainty-health-systems-prioritize-roi/#respond Mon, 27 Mar 2023 12:25:54 +0000 https://medcitynews.com/?p=626637

By evaluating the potential of healthcare operations software investments to affect each of these three key outcomes areas — patient outcomes, workforce outcomes, and risk and compliance outcomes — CIOs can make informed decisions that drive value and improve outcomes for patients, providers, and the entire organization. 

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Top 5 Compliance Issues for Medtech Firms Transitioning To Data-enabled Solutions https://medcitynews.com/2023/01/top-5-compliance-issues-for-medtech-firms-transitioning-to-data-enabled-solutions/ https://medcitynews.com/2023/01/top-5-compliance-issues-for-medtech-firms-transitioning-to-data-enabled-solutions/#respond Fri, 27 Jan 2023 14:00:13 +0000 https://medcitynews.com/?p=621184

Medtech companies should be particularly mindful of the following legal and regulatory compliance issues. This is especially true for companies transitioning to data-based services.

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Top 5 FDA considerations for medtech-enabled data platforms https://medcitynews.com/2023/01/top-5-fda-considerations-for-medtech-enabled-data-platforms/ https://medcitynews.com/2023/01/top-5-fda-considerations-for-medtech-enabled-data-platforms/#respond Tue, 24 Jan 2023 14:43:32 +0000 https://medcitynews.com/?p=621181 FDA sign, headquarters

Medtech companies should have a team of FDA advisors at the ready to develop and implement pre- and post-market strategies, prevent and resolve pre- or post-market issues and guide lifecycle management

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The future of regulatory labeling compliance depends on technology adoption https://medcitynews.com/2022/02/the-future-of-regulatory-labeling-compliance-depends-on-technology-adoption/ https://medcitynews.com/2022/02/the-future-of-regulatory-labeling-compliance-depends-on-technology-adoption/#respond Fri, 11 Feb 2022 23:16:35 +0000 https://medcitynews.com/?p=568510

The life sciences industry is more quickly adapting to new methods, standards and requirements. The focus is now on how to drive greater data governance and quality through a unified framework.  The challenge comes in instituting a framework that will meet regulatory and labeling requirements.

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Audits and penalties possible for noncompliance with new notification, digital contact rules https://medcitynews.com/2022/02/audits-and-penalties-possible-for-noncompliance-with-new-notification-digital-contact-rules/ https://medcitynews.com/2022/02/audits-and-penalties-possible-for-noncompliance-with-new-notification-digital-contact-rules/#respond Fri, 04 Feb 2022 17:48:41 +0000 https://medcitynews.com/?p=567517 A wind torn red warning flag indicating danger on an English beach.

A CMS rule, which went into effect December 31, requires that providers publish up-to-date digital contact information regarding their compliance, using approved methods. Noncompliant hospitals will be publicly listed, akin to the Office of Civil Rights’ breach notification portal, the so-called “Wall of Shame.”

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Only 5% hospitals are compliant with price transparency rule. Here’s how they did it. https://medcitynews.com/2021/07/only-5-hospitals-are-compliant-with-price-transparency-rule-heres-how-they-did-it/ https://medcitynews.com/2021/07/only-5-hospitals-are-compliant-with-price-transparency-rule-heres-how-they-did-it/#respond Mon, 26 Jul 2021 22:45:32 +0000 https://medcitynews.com/?p=542132 provider venture capital, money

The hospitals that were found to be fully compliant with the federal price transparency rule had a few strategies in common, including picking the right technology partner and beginning their efforts early — in some cases before the rule was even proposed.

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CMS proposes fining hospitals up to $2M annually for not following price transparency rule https://medcitynews.com/2021/07/cms-proposes-fining-hospitals-up-to-2m-annually-for-not-following-price-transparency-rule/ https://medcitynews.com/2021/07/cms-proposes-fining-hospitals-up-to-2m-annually-for-not-following-price-transparency-rule/#respond Tue, 20 Jul 2021 22:46:50 +0000 https://medcitynews.com/?p=541157

CMS’ latest proposed rule, which includes stringent penalties for hospitals that are found to be flouting the price transparency rule, comes on the heels of an analysis showing that a vast majority of hospitals are not in compliance with the regulation that went into effect on Jan. 1.

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Compliance with HIPAA may offer some clues on how providers will fare with new info blocking rules https://medcitynews.com/2021/04/compliance-with-hipaa-may-offer-some-clues-on-how-providers-will-fare-with-new-info-blocking-rules/ https://medcitynews.com/2021/04/compliance-with-hipaa-may-offer-some-clues-on-how-providers-will-fare-with-new-info-blocking-rules/#respond Sun, 18 Apr 2021 13:30:50 +0000 https://medcitynews.com/?p=525236 HIPAA, compliance, information blocking,

Despite a 20-year head start, providers still fall short of HIPAA requirements around fulfilling patient requests for their medical records. In light of the federal information blocking rules, providers should first examine their compliance with HIPAA and then address the new demands imposed by the recently enacted regulations.

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Analysis: Most hospitals not complying with price transparency rule   https://medcitynews.com/2021/03/analysis-most-hospitals-not-complying-with-price-transparency-rule/ https://medcitynews.com/2021/03/analysis-most-hospitals-not-complying-with-price-transparency-rule/#respond Wed, 17 Mar 2021 23:16:30 +0000 https://medcitynews.com/?p=520259 provider venture capital, money

The federal price transparency rule for hospitals went into effect Jan. 1, but a new analysis shows that a majority of providers studied were “unambiguously noncompliant.”

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4 signs your compliance program is out of date https://medcitynews.com/2021/03/4-signs-your-compliance-program-is-out-of-date/ https://medcitynews.com/2021/03/4-signs-your-compliance-program-is-out-of-date/#respond Wed, 03 Mar 2021 13:05:16 +0000 https://medcitynews.com/?p=517355

Many players in life sciences and other sectors balk at updating their compliance systems because of the cost and resources involved, but addressing possible lapses now can save your company millions of dollars in fines and reputational damage.

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What providers need to know about OIG’s plans to audit telehealth services https://medcitynews.com/2021/02/what-providers-need-to-know-about-oigs-plans-to-audit-telehealth-services/ https://medcitynews.com/2021/02/what-providers-need-to-know-about-oigs-plans-to-audit-telehealth-services/#respond Tue, 09 Feb 2021 22:56:40 +0000 https://medcitynews.com/?p=514118

The Office of the Inspector General will audit Medicare Part B telehealth services to detect potential vulnerabilities and ensure compliance with regulatory requirements. To prepare, providers must first take stock of their programs and conduct audits of their own, experts say.

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CMS changes to Stark Law appear largely positive, experts say https://medcitynews.com/2020/11/cms-changes-to-stark-law-appear-largely-positive-experts-say/ https://medcitynews.com/2020/11/cms-changes-to-stark-law-appear-largely-positive-experts-say/#respond Wed, 25 Nov 2020 19:19:29 +0000 https://medcitynews.com/?p=505061

CMS has finalized changes to the Physician Self-Referral Law, also known as Stark Law. Healthcare law experts say that these changes will generally make it easier for hospitals and physicians to remain in compliance with the statute.

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Sansoro Health merging with Datica as part of broader health IT consolidation https://medcitynews.com/2019/06/sansoro-health-merging-with-datica-as-part-of-broader-health-it-consolidation/ https://medcitynews.com/2019/06/sansoro-health-merging-with-datica-as-part-of-broader-health-it-consolidation/#respond Wed, 26 Jun 2019 17:42:53 +0000 https://medcitynews.com/?p=463199

The combined company will retain the Datica name and is headquartered in Minneapolis. Sansoro Health CEO Jeremy Pierotti will take on the chief executive role of the new company and former Datica CEO Travis Good will move to the position of chief technology officer.

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The unique challenges of global clinical trial transparency https://medcitynews.com/2018/11/the-unique-challenges-of-global-clinical-trial-transparency/ https://medcitynews.com/2018/11/the-unique-challenges-of-global-clinical-trial-transparency/#respond Mon, 26 Nov 2018 17:32:17 +0000 https://medcitynews.com/?p=447890 Earth planet with global routes and light dots representing global connection and communication.

The implementation of data regulations and an enforcing oversight committee can have a great impact and encourage many trial sponsors to become more transparent with their trials.

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An alarming device trend: Why getting 510(k) clearance alone is not enough https://medcitynews.com/2015/12/why-getting-510k-clearance-not-enough/ https://medcitynews.com/2015/12/why-getting-510k-clearance-not-enough/#respond Wed, 16 Dec 2015 15:00:29 +0000 https://medcitynews.com/?p=360063 Don’t be like Acme Medical Device Company.

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The $400,000 FDA compliance mistake you don’t want to make https://medcitynews.com/2015/09/fda-compliance-mistake-you-do-not-want-to-make/ https://medcitynews.com/2015/09/fda-compliance-mistake-you-do-not-want-to-make/#respond Wed, 23 Sep 2015 12:15:41 +0000 https://medcitynews.com/?p=352428 This is a story I recently heard from a medical device startup who lost over $400,000 dealing with the aftermath of an FDA compliance inspection.

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